Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI
This study has been terminated.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00517192
First received: August 15, 2007
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tipranavir Drug: Darunavir Drug: Ritonavir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion. [ Time Frame: 48 weeks of treatment ]
Secondary Outcome Measures:
- Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure). [ Time Frame: 48 weeks of treatment ]
- Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug. [ Time Frame: 48 weeks of treatment ]
- Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion. [ Time Frame: 48 weeks of treatment ]
- Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF [ Time Frame: up to 48 weeks ]
- Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat [ Time Frame: up to 48 weeks ]
- Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8 [ Time Frame: up to week 8 ]
- Daily Average in CD4+ Cell Count Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]
- Daily Average in CD4+ Cell Count Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]
- Daily Average in Viral Load Change From Baseline up to Week 8 [ Time Frame: up to week 8 ]
- Daily Average in Viral Load Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]
- Daily Average in Viral Load Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]
- Change From Baseline in CD4+ Cell Count up to Week 48 [ Time Frame: up to week 48 ]
- Change From Baseline in log10 Viral Load up to Week 48 [ Time Frame: up to week 48 ]
- Occurrence of New AIDS Progression Events or Death [ Time Frame: through 48 weeks of treatment ]
| Enrollment: | 40 |
| Study Start Date: | September 2007 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced patients (a minimum of 3-months duration for each class) with resistance to more than one protease inhibitor on the screening virtual phenotype resistance testing.
- Patients optimized background regimen must contain at least two active antiretrovirals including Efuvirtide, Maraviroc and integrase inhibitors.
- Patient has been on their current (failing) protease inhibitor-containing regimen for at least 8 weeks prior to randomization.
- An HIV-1 viral load of at least 1,000 copies/mL at screening.
- A CD4+ cell count of at least 50 cells/mm3 at screening.
9. Acceptable screening laboratory values that indicate adequate baseline organ function.
Exclusion Criteria:
- Previous use of Tipranavir (TPV) or Darunavir (DRV).
- Full genotypic resistance (reported as minimal response) to Tipranavir (TPV) or Darunavir (DRV) on screening virtual phenotype:
Female patient of child-bearing potential who:
has a positive serum pregnancy test at screening or during the study, is breast feeding, is planning to become pregnant, is not willing to use barrier methods of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.
- History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
- Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
- Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
- Current use of systemic cytotoxic chemotherapy.
- All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517192
Show 54 Study Locations
Show 54 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00517192 History of Changes |
| Other Study ID Numbers: | 1182.71 |
| Study First Received: | August 15, 2007 |
| Results First Received: | September 18, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products Canada: Health Canada (TPD) France: AFSSAPS Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authorities for Drugs and Medica Greece: National Organization for Medicines (EOF) National Ethics Committee Italy: Comitato Etico Azienda Spedali Civili di Brescia Portugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 Lisboa Spain: Ministry of Health Thailand: Ministry of Public Health United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Darunavir Tipranavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013